Associate Director, Engineering, Pharmaceutical Job

Associate Director, Engineering, Pharmaceutical-PRO014388

Description

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.


This position is for an Associate Director (M2), Engineering in Pharmaceutical Commercialization Technology (PCT). PCT is responsible for pharmaceutical process development of primarily oral solid dosage forms from Formal Stability Study Scale through regulatory filings, process performance qualification, and into the first years of commercial launch. The group’s work is facilitated by a network of pilot plants (SDP in West Point, PA) and commercialization sites (Ireland and Puerto Rico), which form the foundation of development and commercialization capabilities as well as many Merck Supply Sites and various third party locations throughout the world.

The Associate Director is a key technical and business leader of GPC/PCT and is responsible for the development of his or her direct reports, and directs process development activities associated with a portion of the late stage pharmaceutical project portfolio in Pharmaceutical Commercialization Technology. This role directs the efforts of teams responsible for creating and executing process development plans, aligning with clinical supply plans, developing and documenting the knowledge base needed for regulatory filings, and managing the project through early launch and supply steps. The associate director also ensures that interfaces with relevant partner groups - upstream, downstream, and parallel - are managed collaboratively, efficiently, and effectively.

The person in this position may lead several high impact, complex, cross-functional teams as well as initiatives. The Associate Director will be responsible for sponsoring cultural change as well as effectively managing people and resources to support and realize GPC's and Merck's vision. Working knowledge of the concepts of Quality by Design, including risk-based approaches to development, design of experiments, and process modeling, are assets.

Proficiency in good scientific writing practices is required to prepare and review technical reports as well as author CTD sections in support of product registration efforts. The Associate Director should demonstrate competency in all six critical leadership behaviors (focus on customers and patients, make rapid, disciplined decisions, act with courage and candor, build talent, demonstrate ethics and integrity, drive results, and foster collaboration).

Primary activities include, but are not limited to:

Manages a group of approximately 4-6 direct reports.

People development

- Develops staff and builds high performance teams. Ensures Employee Development Plans (EDP) exist and are current for staff, and leverages EDPs to drive development of staff. Ensures staff have given assignments that support their EDPs

- Mentors and coaches direct reports and others in the organization. Uses feedback to improve self and others, and to ensure that customer/stakeholder needs are met.

- Participates in talent management for PCT, and jointly with partner organizations.

- Participates in performance management.

- Understands and applies HR policies.

Advance the pipeline:

- Decides on development plans and outcomes related to the development and implementation of the control strategy for commercial processes.

- Escalates issues appropriately for visibility and resolution within Tier structure.

- As project team leader, develops high-performing teams, or as a key member of multiple smaller teams influences direction for optimal solutions based on use of systematic planning, risk and options analysis tools.

- Identifies resource needs and opportunities to balance the needs of the project portfolio and people development.

- Anticipates and adjusts or redefines goals and plans across teams in response to changes in business needs.

Build capability and strategic thinking

- Influences departmental strategy and tactics.

- Makes informed cost/ benefit decisions based on analysis of inputs, risk and likely return, and takes ownership of the outcomes.

- Leverages communication mechanisms and business processes for technical and business topics to facilitate decision making and leverage the collective experience of the organization.

- Influences interactions with key partner groups, and helps to set strategy and tactics across functions.

- Leads departmental and cross-functional strategic initiatives and demonstrates the necessary collaboration skills to integrate input and perspective from various sources, and demonstrates ability to explain the decision and its implications to key stakeholders.

Technical expertise and contribution, including technology development

- Has fluency of scientific/technical concepts and techniques, applies and furthers those concepts and techniques in pursuit of resolving scientific/technical issues.

- Ensures technical capability build and maintenance of expertise within organization.

- Leads application of Quality by Design (QbD) development in regulatory filings, with an emphasis on process robustness and flexibility with business benefits using enhanced and traditional control strategies.

- Depth and/or breadth in aspects of pharmaceutical process development, particularly for Oral Solid Dosage development, such as standard and enabled formulations and processes, characterization techniques, experimental data analysis and modeling, including statistical and first-principle approaches are considered assets.

Qualifications

Education:

- Bachelor's degree in Chemical Engineering, Materials Science/Engineering, Pharmaceutical Sciences, or related engineering/scientific disciplines required

Required Experience:

- BS with eight (8) years, MS with six (6) years, or PhD with four (4) years of related experience in solid dosage drug product development or other related area.

Preferred Experience:

- Experience as people manager or demonstrated experience in coaching and developing junior staff.

Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at staffingaadar@merck.com.

Search Firm Representatives Please Read Carefully:

Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.

Visa sponsorship is not available for this position.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement​



Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.


Job: Process Engineering

Job Title:Assoc. Dir, Engineering

Primary Location: NA-US-PA-West Point

Employee Status: Regular

Travel: Yes, 20 % of the Time

Number of Openings: 1

Shift (if applicable): N/A

Hazardous Materials: Active Pharmaceutical Ingredients and Pharmaceutical Powders

Company Trade Name:Merck